Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K000779 |
Device Name |
APEXPRO TELEMETRY SYSTEM |
Applicant |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Applicant Contact |
DAVID WAHLIG |
Correspondent |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. |
MILWAUKEE,
WI
53223
|
|
Correspondent Contact |
DAVID WAHLIG |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/10/2000 |
Decision Date | 05/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|